Performance Of Medical Devices Research Articles

Real-world data to support post-market safety and performance of embolization coils: evidence generation from a medical device manufacturer and data institute partnership

BackgroundRecognizing the limitations of pre-market clinical data, regulatory authorities have embraced total product lifecycle management with post-market surveillance (PMS) data to assess medical device safety and performance. One method of proactive PMS involves the analysis of real-world data (RWD) through retrospective review of electronic health records (EHR). Because EHRs are patient-centered and focused on providing tools that clinicians use to determine care rather than collecting information on individual medical products, the process of transforming RWD into real-world evidence (RWE) can be laborious, particularly for medical devices with broad clinical use and extended clinical follow-up. This study describes a method to extract RWD from EHR to generate RWE on the safety and performance of embolization coils.MethodsThrough a partnership between a non-profit data institute and a medical device manufacturer, information on implantable embolization coils’ use was extracted, linked, and analyzed from clinical data housed in an electronic data warehouse from the state of Indiana’s largest health system. To evaluate the performance and safety of the embolization coils, technical success and safety were defined as per the Society of Interventional Radiology guidelines. A multi-prong strategy including electronic and manual review of unstructured (clinical chart notes) and structured data (International Classification of Disease codes), was developed to identify patients with relevant devices and extract data related to the endpoints.ResultsA total of 323 patients were identified as treated using Cook Medical Tornado, Nester, or MReye embolization coils between 1 January 2014 and 31 December 2018. Available clinical follow-up for these patients was 1127 ± 719 days. Indications for use, adverse events, and procedural success rates were identified via automated extraction of structured data along with review of available unstructured data. The overall technical success rate was 96.7%, and the safety events rate was 5.3% with 18 major adverse events in 17 patients. The calculated technical success and safety rates met pre-established performance goals (≥ 85% for technical success and ≤ 12% for safety), highlighting the relevance of this surveillance method.ConclusionsGenerating RWE from RWD requires careful planning and execution. The process described herein provided valuable longitudinal data for PMS of real-world device safety and performance. This cost-effective approach can be translated to other medical devices and similar RWD database systems.

Construction d’une méthodologie d’évaluation clinique des dispositifs médicaux grâce aux outils de simulation et illustration à travers trois études

European regulations have recently moved towards more stringent requirements for demonstrating the safety and performance of medical devices (MDs). To apply an innovative testing method using medical simulation to the evaluation of three medical devices at different stages of their life cycle. The methodology for evaluating DMs using simulation is based on seven stages: definition of the context, training, construction of a scenario to test the DM, validation of the scenario, realization of the scenario, evaluation of the scenario by the players and validation and exploitation of the results. Our evaluation methodology enabled us to assess three DMs at different stages of their development: a respiratory protection device at the initial stage (prototype definition), a respiratory protection mask (prototype optimization) and bottle adapters (post-marketing). Simulation is a valuable tool for evaluating DM. The proposed methodology enables it to be used and adapted to different contexts. It responds to the specificities of clinical evaluation of this class of products, and helps to better anticipate certain risks.

Revolutionizing healthcare materials: Innovations in processing, advancements, and challenges for enhanced medical device integration and performance

Cutting-edge materials have transformed the fabrication of medical devices and implants. However, the processing used to create these materials impacts their mechanical, physical, and biological characteristics, preventing effective integration. This study is intended to provide a detailed analysis of healthcare materials processing techniques, stressing healthcare-specific material requirements, such as biocompatibility, mechanical strength, corrosion resistance, stabilizability, and bioactivity, followed by classifying these processing methods as “ordinary” and “edge-cutting” methods. The consequences of each processing on the material, as well as the benefits, drawbacks, and recent developments of each technique, are also aimed to be concluded. The study also aimed to explore how process factors affect product qualities. The articles are collected from the Scopus and Web of Science databases using the search strings “Advance Material,” “Material Processing,” “Healthcare,” and “HealthCare Application.” The assessment of the selected literature has been done in accordance with the objectives. The assessment emphasizes quality assurance and regulatory compliance by stressing the need for quality assurance, characterization, and testing for medical devices and implants. Processes such as polishing, etching, and coatings improve biocompatibility and reduce infection risk, according to the findings. It was also concluded that cutting-edge processing methods such as additive manufacturing (3D printing) and electrospinning provide exact control over material composition, structure, and porosity, making them ideal for many clinical applications.

Steps Toward Recapitulating Endothelium: A Perspective on the Next Generation of Hemocompatible Coatings.

Endothelium, the lining in this blood vessel, orchestrates three main critical functions such as protecting blood components, modulating of hemostasis by secreting various inhibitors, and directing clot digestion (fibrinolysis) by activating tissue plasminogen activator. No other surface can perform these tasks; thus, the contact of blood and blood-contacting medical devices inevitably leads to the activation of coagulation, often causing device failure, and thromboembolic complications. This perspective, first, discusses the biological mechanisms of activation of coagulation and highlights the efforts of advanced coatings to recapitulate one characteristic of endothelium, hereafter single functions of endothelium and noting necessity of the synergistic integration of its three main functions. Subsequently, it is emphasized that to overcome the challenges of blood compatibility an endothelium-mimicking system is needed, proposing a synergy of bottom-up synthetic biology, particularly synthetic cells, with passive- and bioactive surface coatings. Such integration holds promise for developing advanced biomaterials capable of recapitulating endothelial functions, thereby enhancing the hemocompatibility and performance of blood-contacting medical devices.

NON-DESTRUCTİVE TESTİNG (NDT) APPLİCATİONS İN ENSURİNG THE RELİABİLİTY AND SAFETY OF MEDİCAL EQUİPMENT: A COMPREHENSİVE REVİEW

The increasing complexity and criticality of medical equipment in healthcare settings demand rigorous testing methodologies to ensure their reliability and safety. This paper explores the diverse applications of Non-Destructive Testing (NDT) in the realm of medical equipment testing. NDT techniques, traditionally employed in industries such as aerospace and manufacturing, offer unique advantages for assessing the structural integrity, functionality, and performance of medical devices without causing harm. The paper begins by providing an overview of NDT principles and methodologies, highlighting their non-invasive nature and ability to detect flaws and defects at an early stage. Subsequently, it delves into the specific NDT techniques applicable to medical equipment, including ultrasound, radiography, magnetic particle testing, and eddy current testing. Each technique's principles, advantages, and limitations are discussed in the context of medical device testing. Furthermore, the paper reviews real-world case studies and examples where NDT has been successfully applied to assess the quality and reliability of various medical equipment, ranging from imaging devices to surgical instruments. The challenges and potential limitations of implementing NDT in the medical field are also addressed, along with suggestions for overcoming these obstacles. In conclusion, this comprehensive review emphasizes the pivotal role of NDT in ensuring the integrity and safety of medical equipment. By leveraging NDT techniques, healthcare professionals can enhance the quality assurance processes, minimize the risk of equipment failure, and ultimately contribute to the improvement of patient outcomes. This paper aims to serve as a valuable resource for researchers, practitioners, and stakeholders in the healthcare and NDT communities, fostering a deeper understanding of the synergies between these two critical domains. Keywords: Non-Destructive Testing (NDT), Medical Equipment, Reliability, Safety, Quality Assurance.

Finite Element Analysis and Mechanical Assessment for the Constraint of Total Knee Replacement

The constraint level of TKR is essential for ensuring product performance to prevent knee joint dislocation. Computer modeling and simulation (CM&S) technology is widely used in the medical device industry due to its advantages such as reducing testing time and costs. However, there is a lack of research on the constraint level of TKR according to the size and flexion angle of the femoral component. In this study, the constraint levels of AP draw, ML shear, and rotary laxity were tested according to the size and flexion angle of TKR products using finite element analysis. A TKR model was constructed using a 3D scanner, and a finite element model with mechanical testing and error rates of 2.49% and 3.00% was developed through AP draw testing. In AP draw, as the size of TKR decreases, the constraint level increases by about 3.6%, and rotary laxity also increases by about 1.3%. In all tests, the constraint level increased as the bending angle of the femoral component increased. We found that the curvature and contact area of a TKR influenced the constraint level. Through this study, it is believed that CM&S technolaogy can be widely used in evaluating the unique performance of medical devices.

State-of-the-art model for derivation of analytical performance specifications: how to define the highest level of analytical performance technically achievable.

To be accurate and equivalent among assays, laboratory results should be traceable to higher-order references and their quality should fulfill maximum allowable measurement uncertainty (MU) as defined to fit the intended clinical use. Accordingly, laboratory professionals should estimate and validate MU of performed tests using appropriate analytical performance specifications (APS). Current consensus supports the derivation of APS by using one of the three models established by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Strategic Conference held in Milan in 2014. It is recognized that some models are better suited for certain measurands than for others and the attention should be primarily directed towards their biological and clinical characteristics. Among others, model 3 should reflect the state of the art of the measurements that can be defined as the best analytical performance that is technically achievable. Taking serum C-reactive protein and ferritin as examples, here we describe the theoretical premises and the experimental protocol to be used to derive APS for MU when a measurand is allocated to this model. Although the model lacks a direct relationship with clinical outcomes, useful information about the invitro diagnostic medical device performance and the average quality of provided results may be obtained.

Exploration of Application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices: Take Artificial Joint Products as Example

Through the effective application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (EP), to continuously improve the corresponding management tools to ensure the safety and effectiveness of medical device in the quality management system, risk management system, evaluation of safety and effectiveness for the supervision departments and manufacturers. The current status of the application of EP and the application issues are analyzed in the study. Take artificial joint products for example, the idea of using EP in quality management system, risk management system and evaluation of safety and effectiveness is investigated, and several thoughts are proposed. Supervision departments should strengthen the unified understanding of EP, develop requirements according to the classification of medical device，and refine specific execution requirements.

Navigating regulatory landscape: A qualitative exploration of medical devices and in vitro diagnostic medical devices oversight in Zimbabwe through key stakeholder perspectives.

Medical devices and In Vitro Diagnostics (IVDs) are vital for public health and accessible healthcare. Still, there is an imbalance in high-quality products in Low and Middle-Income Countries (LMICs). Zimbabwe's regulatory framework for medical devices and IVDs is unclear, leading to ineffective compliance and surveillance. As a result, there are knowledge gaps regarding pre-market and post-market regulatory elements to ensure the safety, quality and performance of medical devices and IVDs used in Zimbabwe. Our study aimed to explore the current status of medical devices and IVD regulations in Zimbabwe. Semi-structured interviews were conducted with 12 regulators from the Medicines Control Authority of Zimbabwe (MCAZ) National Microbiology Reference Laboratory (NMRL), Medical Laboratory and Clinical Scientists Council (MLCScCZ) to understand the current status of medical devices and IVD regulations in Zimbabwe. Three participants completed a questionnaire to understand the regulatory landscape in Zimbabwe. Three key informant interviews were conducted with three regulators from the South African Health Products Regulatory Authority (SAHPRA), Tanzanian Medicines and Medical Devices Authority (TMDA), and World Health Organization Regulatory Systems Strengthening (WHO RSS) to learn best practices to create a roadmap for Zimbabwe. We analyzed qualitative data using a thematic analysis. The findings reveal significant deficiencies and gaps in the legal framework for regulating medical devices and IVDs, highlighting the need for a legal framework and the absence of more comprehensive regulations. Regulatory entities face capacity limitations, especially in regulating medical devices and IVDs. Conformity assessment processes, medical devices, IVD classification criteria, and post-market surveillance also represent challenges, highlighting the need for a well-defined framework and regulatory procedures. The Zimbabwean regulatory system pathway is reactive, prompting several regulatory initiatives to address needs. Despite facing challenges, there is recognition of the importance of collaboration among regulatory authorities, emphasizing a shared commitment to improving and strengthening medical devices and IVD regulations for improved patient safety. By advocating for a proactive, comprehensive, and legally sound approach, indicating the potential for collaboration and synergy, this study provides a foundation for well-informed policy recommendations to guide enhancements and build a framework for a resilient, efficient, and transparent regulatory environment in the Zimbabwe and African regions as a whole.

Dapansutrile OLT1177 suppresses foreign body response inflammation while preserving vascularisation of implanted materials.

Mitigating inflammation associated with the foreign body response (FBR) remains a significant challenge in enhancing the performance of implantable medical devices. Current anti-inflammatory approaches aim to suppress implant fibrosis, the major outcome of the FBR, but also inadvertently inhibit beneficial immune signalling necessary for tissue healing and vascularization. In a previous study, we demonstrated the feasibility of 'selective' immunosuppression targeting the NLRP3 inflammasome using the small molecule inhibitor MCC950, leading to reduced implant fibrosis without compromising healing and leading to enhanced vascularization. However, the clinical potential of MCC950 is severely limited due to its failure to pass Phase I clinical safety trials. This has triggered substantial efforts to develop safer analogues of NLRP3 inhibitors. Dapansutrile (OLT1177) is emerging as a leading candidate amongst current NLRP3 inhibitors, demonstrating both safety and effectiveness in a growing number of clinical indications and Phase 2 trials. While the anti-inflammatory effects of OLT1177 have been shown, validation of these effects in the context of implanted materials and the FBR have not yet been demonstrated. In this study, we show OLT1177 possesses beneficial effects on key cell types which drive FBR outcomes, including macrophages, fibroblasts, and smooth muscle cells. Evaluation of OLT1177 in a 28 day subcutaneous implantation model showed OLT1177 reduced fibrotic capsule formation while promoting implant vascularization. Mechanistic studies revealed that this occurred through activation of early pro-angiogenic markers while suppressing late-stage anti-angiogenic markers. These findings establish OLT1177 as a promising therapeutic approach for mitigating implant fibrosis while supporting vascularisation, suggesting a highly promising selective immunosuppressive strategy for the FBR warranting further research to explore its optimal integration into medical materials and devices.

An insect sclerotization-inspired antifouling armor on biomedical devices combats thrombosis and embedding

Thrombus formation and tissue embedding significantly impair the clinical efficacy and retrievability of temporary interventional medical devices. Herein, we report an insect sclerotization-inspired antifouling armor for tailoring temporary interventional devices with durable resistance to protein adsorption and the following protein-mediated complications. By mimicking the phenol-polyamine chemistry assisted by phenol oxidases during sclerotization, we develop a facile one-step method to crosslink bovine serum albumin (BSA) with oxidized hydrocaffeic acid (HCA), resulting in a stable and universal BSA@HCA armor. Furthermore, the surface of the BSA@HCA armor, enriched with carboxyl groups, supports the secondary grafting of polyethylene glycol (PEG), further enhancing both its antifouling performance and durability. The synergy of robustly immobilized BSA and covalently grafted PEG provide potent resistance to the adhesion of proteins, platelets, and vascular cells in vitro. In ex vivo blood circulation experiment, the armored surface reduces thrombus formation by 95 %. Moreover, the antifouling armor retained over 60 % of its fouling resistance after 28 days of immersion in PBS. Overall, our armor engineering strategy presents a promising solution for enhancing the antifouling properties and clinical performance of temporary interventional medical devices.

5G-Enabled Healthcare in Mobile Scenarios: Challenges and Implementation Considerations.

Wireless connectivity delay, disruption, or failure can significantly affect the performance of wireless-enabled medical devices, which in turn causes potential risks to the patient. Notably, the challenges related to connectivity provisioning are exacerbated in the fifth-generation (5G)-enabled healthcare use cases where mobility is utilized. In this article, we describe relevant 5G-enabled healthcare use cases involving mobility and identify the connectivity challenges that they face. We then illustrate practical implementation considerations, tradeoffs, and future research directions for enabling reliable 5G healthcare transmissions. This is done through simulation of connected ambulances as an example use-case.

Critical assessment of medical devices on reliability, replacement prioritization and maintenance strategy criterion: Case study of Malaysian hospitals

AbstractThe Biomedical Engineering Maintenance Services (BEMS) is a comprehensive maintenance program that ensures the safety and reliability of medical devices. Significant and crucial devices are identified and prioritized for best practice prior to the equipment life cycle to mitigate functional problems, alarmed by the Fourth Industrial Revolution (4IR) underlying the modernization agenda. A model of multi‐criteria decision‐making (MCDM) to prioritize medical devices according to their criticality is presented in this paper, with the utilization of quality function deployment (QFD) and fuzzy logic in the development of the model through a quantitative survey of experts from all regions in Malaysia. As a result, a customized version of the Asset Criticality Assessment (ACA) is developed and is recommended for use in more than 144 Ministry of Health (MOH) hospitals. Subsequently, real data of four selected devices are pulled from the Asset and Services Information System (ASIS) to demonstrate a relevant and comparable end‐result using the QFD and fuzzy logic. In essence, the key contribution of the customized ACA model is that it assesses a promising evaluation with a broader range on both the performance of medical devices and the appropriate asset replacement choices. This leads to an effective maintenance strategy for each device and the modernization of reliability computation metrics.

Betainization of Polydopamine/Polyethylenimine Coating for Universal Zwitterionization.

Biofoulants can adhere to multiple surfaces, degrading the performance of medical devices and industrial facilities and/or causing nosocomial infection. The surface immobilization of zwitterionic materials can prevent the initial attachment of the foulants but lacks extensive implementation. Herein, we propose a facile, universal, two-step surface modification strategy to improve fouling resistance. In the first step, the substrates were immersed in a codeposition solution containing dopamine and branched polyethylenimine (PEI) to form a "primer" layer (PDA/PEI). In the second step, the primer layers were treated with 1,3-propane sultone to betainize primary/secondary/tertiary amine moieties of PEI, generating zwitterions on substrates. After betainization, PS-grafted PDA/PEI (PDA/PEI/S) via a ring-opening alkylation reaction manifested changes in wettability. X-ray photoelectron spectroscopy revealed the presence of zwitterionic moieties on the PDA/PEI/S surfaces. Further investigations using ellipsometry and atomic force microscopy were conducted to scrutinize the relation among the PEI content, film thickness, primer stability, and betainization. As a result, zwitterion-decorated substrates prepared under optimal conditions can exhibit high resistance against bacterial fouling, achieving a 98.5% reduction in bacterial attachment. In addition, the method shows a substrate-independent property, capable of successfully applying it on organic and inorganic substrates. Finally, the newly developed approach shows excellent biocompatibility, displaying no significant difference compared with blank control samples. Overall, we envision that the facile surface modification strategy can further promote the preparation of zwitterion-decorated materials in the future.

Mechanical characterisation of commercial artificial skin models

Understanding of the mechanical properties of skin is crucial in evaluating the performance of skin-interfacing medical devices. Artificial skin models (ASMs) have rapidly gained attention as they are able to overcome the challenges in ethically sourcing consistent and representative ex vivo animal or human tissue models. Although some ASMs have become commercialised, a thorough understanding of the mechanical properties of the skin models is crucial to ensure that they are suitable for the purpose of the study. In the present study, skin and fat layers of ASMs (Simulab®, LifeLike®, SynDaver® and Parafilm®) were mechanically characterised through hardness, needle insertion, tensile and compression testing. Different boundary constraint conditions (minimally and highly constrained) were investigated for needle insertion testing, while anisotropic properties of the skin models were investigated through different specimen orientations during tensile testing. Analysis of variance (ANOVA) tests were performed to compare the mechanical properties between the skin models. Properties of the skin models were compared against literature to determine the suitability of the skin models based on the material property of interest. All skin models offer relatively consistent mechanical performance, providing a solid basis for benchtop evaluation of skin-interfacing medical device performance. Through prioritising models with mechanical properties that are consistent with human skin data, and with limited variance, researchers can use the data presented here as a toolbox to select the most appropriate ASM for their particular application.

Application of Overall Equipment Effectiveness for Optimizing Ventilator Reliability in Intensive Care Units and Emergency Departments

Healthcare organizations seek to offer a comprehensive medical services system framework with safety and high quality. This needs continuously developing integrated governance systems that provide safe, reliable, and maintaining high-quality care and value-based care for patients. In addition to improving access to health services in time, increasing efficiencies in providing medical services, reducing the risk-based medical services, and selecting a suitable maintenance policy for maintaining the medical devices. This paper adopted a quantitative analysis method based on Reliability-Based Maintenance (RCM) to comprehensively evaluate the overall medical equipment's effectiveness. RCM is an integrated approach to continuous improvement of the maintenance programs because it can predict early medical equipment failure and determine the mean time between failures. It also assesses the risk level to the patient's life in case of a medical equipment breakdown while provisioning medical services. This study targeted biomedical engineering, intensive care units, and emergency departments at 24 public hospitals in a top 20 OECD country. It selected these departments due to the rise in the rate of patients needing ventilator equipment availability during COVID-19, risk based on the sudden breakdown of the ventilator machines, and increasing the annual budget percentage required to provide medical services, where 239 of the ventilator equipment were investigated. Staff Experience-based Evidence was adopted to collect data by interviewing staff and distributing the survey. The study found that the average OEE for ventilator devices in Intensive Care Units and Emergency Departments was 63%. The device's performance was rated at 65%, while its availability and quality rate were both rated at 100%. These findings suggest that the use of the OEE metric has improved ventilator device reliability and performance in selected hospitals. The OEE metric may have potential benefits for improving the performance of other medical devices as well.

Blockchain-assisted authenticated key agreement scheme for IoT-based healthcare system

IoT devices are widely used in smart hospitals, digital health, and automated pathology laboratories to generate a large amount of heterogeneous data. These devices, coupled with medical sensors, enable healthcare professionals to monitor patients’ health and medical device performance in real-time. The collected health data is transmitted to centralized cloud servers for analysis and diagnosis. However, the wireless communication channels used by these devices are vulnerable to security threats such as unauthorized access, denial-of-service attacks, and man-in-the-middle attacks. Existing solutions rely on a single trusted authority for computing and storage, which can lead to issues such as higher latency, centralization, and a single point of failure. To address these concerns, we propose a new protocol called Blockchain-based IoMT Authenticated Key Exchange (BIoMTAKE) that establishes a private/consortium blockchain-based distributed environment using Hyperledger Fabric. This protocol eliminates the need for a single trusted authority and ensures secure access to data generated by IoMT devices. Before sharing or accessing any data from the distributed healthcare system, the BIoMTAKE scheme establishes a secured shared session for authenticated devices to prevent unauthorized access. The proposed methodology has been subjected to formal security analysis using the Scyther tool and informal security analysis, which demonstrates its strong security. Additionally, our performance analysis using Hyperledger Fabric and cryptography libraries shows that the proposed scheme is computationally and communicatively efficient.

BT09 Clinical performance of an artificial intelligence-based medical device deployed within an urgent suspected skin cancer pathway

Abstract A secondary care trust received over 2800 urgent suspected skin cancer referrals (USCRs) in 2021, 50% more than in 2016 (www.england.nhs.uk/statistics/statistical-work-areas/cancer-waiting-times), < 1 in 10 of which resulted in diagnosis of skin cancer (www.cancerdata.nhs.uk/cwt_conversion_and_detection). Judicious implementation of artificial intelligence (AI) may improve referral accuracy. We conducted a prospective, postdeployment, single-centre clinical performance review of a UK Conformity Assessed Class IIa-approved, AI-based, skin lesion analysis medical device intended for use in the screening, triage and assessment of skin lesions suspicious for skin cancer (AIaMD). The AIaMD is deployed at the trust as a decision-support tool following USCR from primary care, with a second read of all cases by a consultant dermatologist. Patients assessed by the two most recent versions of AIaMD from October 2021 to October 2022 were eligible for inclusion. Outcomes were confirmed from histology reports for cancerous lesions and histology reports or Consultant teledermatology assessment for noncancerous lesions. The AIaMD assessed 1363 lesions with outcomes confirmed, including 51 melanomas, 64 squamous cell carcinomas (SCCs), 96 basal cell carcinomas, 8 rare skin cancers and 244 premalignancies. The AIaMD referral sensitivity for melanoma, all skin cancer and premalignancy was 100% (n = 51/51), 99.5% (n = 218/219) and 96.3% (n = 235/244), respectively. The AIaMD benign lesion specificity was 55.9% (n = 434/777). The negative predictive value (how often AIaMD labelled lesions as premalignant/benign and correctly ruled out cancer) was 99.8% (n = 539/540). The conversion rate (the percentage of lesions classified as high risk by AIaMD that resulted in a diagnosis of melanoma or SCC) was 13.8% (n = 122/886), while the USCR conversion in the local clinical commissioning group was 9.9% in 2020–2021. The service discharged 9.4% (n = 239/2551) of patients during this time without using trust dermatologist capacity, with the potential to have discharged 18.3% (n = 467/2551) without a second read. This postmarket service evaluation reported the clinical outcomes of an AI device used for assessment of skin lesions. The pathway was sensitive, identifying 218 of 219 skin cancers, and specific, correctly identifying over half of benign lesions. Moreover, AIaMD was able to improve the conversion rate of USCRs. The integration of AIaMD into skin cancer diagnostic pathways could significantly improve the accuracy of USCRs. Conflicts of interest: these were commercial deployments of the AI, and three of the authors are employed by the AI provider.

Towards the simulation of bone-implant systems with a stratified material model.

The clinical performance of medical devices is becoming increasingly important for the requirements of modern development processes and the associated regulations. However, the evidence for this performance can often only be obtained very late in the development process via clinical trials or studies. The purpose of the presented work is to show that the simulation of bone-implant systems has advanced in various aspects, including cloud-based execution, Virtual Clinical Trials, and material modeling towards a point where and widespread utilization in healthcare for procedure planning and enhancing practices seems feasible. But this will only hold true if the virtual cohort data build from clinical Computer Tomography data are collected and analysed with care. An overview of the principal steps necessary to perform Finite Element Method based structural mechanical simulations of bone-implant systems based on clinical imaging data is presented. Since these data form the baseline for virtual cohort construction, we present an enhancement method to make them more accurate and reliable. The findings of our work comprise the initial step towards a virtual cohort for the evaluation of proximal femur implants. In addition, results of our proposed enhancement methodology for clinical Computer Tomography data that demonstrate the necessity for the usage of multiple image reconstructions are presented. Simulation methodologies and pipelines nowadays are mature and have turnaround times that allow for a day-to-day use. However, small changes in the imaging and the preprocessing of data can have a significant impact on the obtaind results. Consequently, first steps towards virtual clinical trials, like collecting bone samples, are done, but the reliability of the input data remains subject to further research and development.

Changes to the medical device regulatory framework: Looking back – and forward

The new regulatory framework for medical devices was long due. It aims to improve the safety and performance of medical devices and ensure a high level of protection for public health. Yet complying with the new legislation requires greater administrative effort and more resources, thus making compliance more expensive. In addition, there has been some uncertainty among researchers about how to correctly comply with the new legislation. This article looks back at the measures swissethics has taken to address some of these challenges and looks forward to additional measures to be implemented in the future.